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Health Behavior News Service
A recent systematic review calls into question the health benefits of pioglitazone (Actos, Takeda/Lilly).1
"Our results showed that published scientific studies of at least 24 weeks of pioglitazone treatment in people with type 2 diabetes mellitus did not provide convincing evidence that patient-oriented outcomes like mortality, morbidity, adverse effects, and health-related quality of life are positively influenced by this drug," says lead author Bernd Richter, MD, of Heinrich-Heine University in Düsseldorf, Germany. "Until new evidence becomes available, the benefit-to-risk ratio of pioglitazone therapy in type 2 diabetes mellitus remains unclear."
According to Richter, the review demonstrated no clear-cut benefit to using pioglitazone, and also showed an increased occurrence of edema and heart failure, including heart failure requiring hospital admission.
The authors analyzed 22 randomized clinical trials involving 6,200 patients with type 2 diabetes receiving pioglitazone treatment. The longest duration of pioglitazone therapy received by any patient was 34.5 months.
Pioglitazone lowers glycated hemoglobin (A1C), but when compared with other active glucose-lowering drugs, which achieved similar reductions, "no apparent advantage of pioglitazone treatment could be demonstrated," Richter says. "Probably, the best comparison would be with metformin, where pioglitazone lowered A1C [by] 1.3–1.4% and metformin by 1.5%."
SIDE EFFECTS
Possible side effects of pioglitazone include fluid retention, weight gain, and leg and ankle edema. In isolated cases it may lead to, or worsen, heart failure. In the review studies, 15% of participants receiving pioglitazone therapy reported edema compared with 7% of participants in control groups.
The 15 studies that looked at body weight reported an increase of up to 3.9 kg (8.6 lb) in patients receiving pioglitazone treatment.
The drug also may cause dangerous drops in blood glucose in people taking it in combination with insulin or sulfonylureas.
MORE DATA NEEDED
"The kernel from this review is that pioglitazone is effective in glucose-lowering, has some other beneficial and potentially harmful associated features, and just has not been evaluated in the right way to prove that it will help people lead longer and more productive lives," says John Buse, MD, director of the Diabetes Care Center at University of North Carolina in Chapel Hill. "This is true for essentially every drug available for the treatment of diabetes.
"I am fairly certain that we are better off with pioglitazone than without it," Buse adds. "We do not have proof, but a great deal of signal that the benefits outweigh the risks. There are more data to come. The authors of the review are not incorrect in their assessments, but there are just not enough long-term data available in the literature to be certain of the benefits, whereas the risks are much easier to assess."
Richter maintains that pioglitazone treatment should be restricted to patients demonstrating real benefit.
"Benefit should not be postulated on the basis of improvement of
metabolic parameters like A1C reduction alone, but should refer to
patient-oriented outcomes such as fewer diabetic complications or better
health-related quality of life," Richter says. 
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| DOC News | Diabetes | Diabetes Care | Clinical Diabetes | Diabetes Spectrum |
